Chronic Thromboembolic Pulmonary Hypertension, Sleep Disordered Breathing
Conditions
Brief summary
There is evidence for a high prevalence of Sleep Disorder Breathing (SDB) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Central Sleep Apnea, Cheyne-Stokes Breathing and Obstructive Sleep Apnea appear to occur in CTEPH. However, there is no information on the impact of CTEPH treatment modalities on concomitant SDB. Furthermore, the use of PAP therapy in CTEPH has not yet been investigated. CTEPH is a rare and serious disease and there may be a bidirectional association of SDB and CTEPH. This study plans to investigate the prevalence of SDB in CTEPH and compare it to datasets of large epidemiological studies on SDB. Furthermore, the impact of CTEPH treatment on SDB will be analyzed and CTEPH patients for possible PAP treatment will be defined.
Interventions
DRUGRiociguat
Patients will be treated with Riociguat according to guidelines (2015 ERS/ESC guidelines for the diagnosis and treatment of pulmonary hypertension) and manufacturers recommendation.
PROCEDUREPulmonary Endarteriectomy
Patients will receive Pulmonary Endarteriectomy if they are suitable for this procedure according to the recommendation of the local CTEPH board. Patients must also consent to this surgical procedure.
PROCEDUREBallon Pulmonary Angioplasty
Patients will receive Ballon Pulmonary Angioplasty if they are suitable for this procedure according to the recommendation of the local CTEPH board (e.g. not suitable for PEA). Patients must also consent to this procedure.The BPA will be accomplished in several interventions.
Sponsors
Medical University of Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recently diagnosed untreated CTEPH * NYHA I-III
Exclusion criteria
* Age\<18 * Pulmonary Hypertension other than CTEPH * Previous diagnosis of SDB * Ongoing PAP treatment * Use of nasal oxygen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AHI change under CTEPH treatment | 6 months | Change from baseline AHI (Apnoe-Hypopnoe Index, events/h) after 6 months of CTEPH treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with persisting elevated AHI (= ≥15/h) after CTEPH treatment | Time point: 6 months after the individual start of the CTEPH treatment | Patients with persisting elevated AHI will be assessed for further PAP treatment |
Countries
Austria
Outcome results
None listed